PT Elite Premium Pain Relief
- Product NDC
- 85808-615
- 11-digit product format
- 858080615
- Labeler code
- 85808
- Product ID
- 85808-615_3a81868c-3aa7-5e51-e063-6294a90a2952
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CAPSAICIN, MENTHOL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- PT ELITE PRODUCTS LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-09
- Substance
- CAPSAICIN; MENTHOL
- Active strength
- .35; 40 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PT Elite Premium Pain Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAPSAICIN | .35 mg/mL |
| MENTHOL | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| S07O44R1ZM | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1865193 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ad251821-4c58-425d-bdcb-8dd9bd41b713 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85808-615-00 | PT Elite Premium Pain Relief | 100 mL in 1 TUBE | CREAM | 100 | 2 | |
| 85808-615-00 | PT Elite Premium Pain Relief | 1 in 1 BOX | CREAM | 1 | 2 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hemorrhoidal Pain Relief Cream | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | WALGREENS | 03bbe146-f185-bcfa-e063-6394a90a85bf | 2023-12-04 | Warnings | M017 |
| Quatriderm Anti-itch | HYDROCORTISONE | OPMX LLC | 83e59e10-9878-e5c2-e053-2a91aa0af25e | 2023-12-04 | Warnings | M017 |
| TACT | DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL | Sato Pharmaceutical Inc., Ltd. | b6e2ee24-69de-4dfd-9081-b9537b7a7bad | 2023-12-04 | Warnings | M017 |
| Overnight Cold Therapy Pain Relief | MENTHOL, UNSPECIFIED FORM | Walgreen Co. | 2cbd0966-4cf9-4271-bd53-6672b1ed2a99 | 2023-12-04 | Warnings | M017 |
| Prolayed Lidocaine Male Genital Desensitizer | LIDOCAINE | ViaDerma Distribution, Inc. | 9c5ad0d0-ca7a-4321-9334-f06f3f6be18f | 2023-12-02 | Warnings | M017 |
| Liberdol Topical Analgesic | METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC) | ViaDerma Distribution, Inc | ab52cd0e-34fa-41c7-9ce7-1183c2aff8d8 | 2023-12-01 | Warnings | M017 |
| Prolayed | LIDOCAINE | MATRIX MIXOLOGY, INC | ae317876-adb1-6d13-e053-2995a90a74af | 2023-12-01 | Warnings | M017 |
| Tact Cool Jelly | DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL | Sato Pharmaceutical Co., Ltd. | f34872c9-91b9-49db-8e41-5b54a069284a | 2023-12-01 | Warnings | M017 |
| Satohap | METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL | Sato Pharmaceutical Co., Ltd. | 348fde05-2797-4410-a1b2-99e64187c4fe | 2023-12-01 | Warnings | M017 |
| Menthozen Hydrogel | MENTHOL, CAPSAICIN | Proficient Rx LP | 85a7809e-c43f-4138-a85b-44e1b586def5 | 2023-12-01 | Warnings | M017 |
| Menthozen Cream | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Proficient Rx LP | 66681906-c5f5-4c57-bb43-9c83cccc0062 | 2023-12-01 | Warnings | M017 |
| Lidozen Patch | LIDOCAINE, MENTHOL | Proficient Rx LP | c0df4b8b-2679-4652-9144-a8db916a186b | 2023-12-01 | Warnings | M017 |
| Lidozen Gel | LIDOCAINE HYDROCHLORIDE, MENTHOL | Proficient Rx LP | 7c300dec-cefd-4b79-a948-a917b7708a04 | 2023-12-01 | Warnings | M017 |
| Menthozen | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Proficient Rx LP | 2adf3c4d-636f-4e02-b501-946b4df5f5d6 | 2023-12-01 | Warnings | M017 |
| Lidozen | LIDOCAINE, MENTHOL | Proficient Rx LP | 488d665c-a4fe-4a69-bab3-34b2347f4b05 | 2023-12-01 | Warnings | M017 |
| Thera Plus Max Strength Lidocaine Pain Relief Liquid | LIDOCAINE HYDROCHLORIDE | Fourstar Group USA, Inc. | 0a228b06-0e1c-6c75-e063-6294a90a9a0e | 2023-11-30 | Warnings | M017 |
| Thera Plus Cool and Heat Pain Relieving Gel Menthol | MENTHOL | Fourstar Group USA, Inc. | 0a225714-ccb1-4676-e063-6294a90aeeb2 | 2023-11-30 | Warnings | M017 |
| Bloop Itch Soothing Topical | HYDROCORTISONE | Three Nations Corp | 0b64677e-d4bf-0929-e063-6294a90af137 | 2023-11-30 | Warnings | M017 |
| Ice Quake | MENTHOL | Southern Sales & Service, Inc. | 7a05832f-49ac-4013-b240-4405501e45cd | 2023-11-29 | Warnings | M017 |
| ICE MUSCLE RUB Leon M.C | MENTHOL | Southern Sales & Service, Inc. | 4efaf347-7406-4690-8005-e7cf2e3d4222 | 2023-11-29 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1865193 | capsaicin 0.035 % / menthol 4 % Topical Cream | PSN | ad251821-4c58-425d-bdcb-8dd9bd41b713 | 2 |
| 1865193 | capsaicin 0.35 MG/ML / menthol 40 MG/ML Topical Cream | SCD | ad251821-4c58-425d-bdcb-8dd9bd41b713 | 2 |
| 1865193 | capsaicin 0.035 % / menthol 4 % Topical Cream | SY | ad251821-4c58-425d-bdcb-8dd9bd41b713 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85808-615-00 | 85808061500 | 1 TUBE in 1 BOX (85808-615-00) / 100 mL in 1 TUBE | 1 tube | 2025-05-09 | No | No | Current |